Primary:To compare the effect of 6 months use of the CIS on adherence to ELLIPTA maintenance therapy when both the subject and the HCP are supplied with data from the maintenance sensor versus no data supplied to the subject and HCP (Arm 1 vs Arm 5…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of ELLIPTA doses between the beginning of month 4 and the end of
month 6 as determined by the maintenance sensor.
Secondary outcome
Percentage of ELLIPTA doses between the beginning of month 4 and the end of
month 6, beginning of month 1 and the end of month 3 and beginning of month 1
and the end of month 6 as determined by the maintenance sensor. Percentage of
rescue free days and total rescue use measured between the beginning of month 4
and the end of month 6 as determined by the rescue sensor records of date,
time, and number of inhaler actuations. Change from baseline in ACT total score
at Month 6, measured at baseline and Month 6. Percentage of patients becoming
controlled as defined as an ACT score *20 at Month 6. Percentage of patients
with an increase from baseline * 3 in ACT total score at Month 6. Adverse
events.
Background summary
GSK has, in collaboration with Propeller Health, developed a sensor which clips
on to the ELLIPTA dry powder inhaler (DPI), herein referred to as ELLIPTA. The
sensor will measure when the ELLIPTA mouth piece cover is fully opened and
closed and this data can be fed back, via an application (app) on a smart phone
to the patient. This will inform a patient if/when a dose of Relvar has been
actuated from the ELLIPTA. Other information, including: asthma management
strategies, tracking of symptoms, asthma triggers and medication reminders,
will also be provided via the app. Information from a second sensor on a
patient*s rescue medication metered dose inhaler (MDI) could also provide
feedback, via the app, to the patient on their salbutamol (albuterol) MDI use.
The data from both Relvar ELLIPTA and salbutamol MDI can also be shared, via an
online dashboard, with the patient*s investigator. The sensors, app, dashboard
and systems to provide data are subsequently described as the Connected Inhaler
System (CIS).
This study will be the first to evaluate the effect of the CIS on adherence to
maintenance therapy (Relvar ELLIPTA) in uncontrolled asthmatic patients (Asthma
Control Test [ACT] <20 at the screening visit and ACT <20 at a subsequent
randomization visit after run-in). The run-in exists to ensure a stable level
of control prior to entry into the study, given the possible change in
treatment.
Relvar ELLIPTA has been registered in the Netherlands for the treatment of e.g.
bronchial asthma. It is a combination of a dry powder formulation of a
corticosteroid and a long acting bronchodilator in a once daily schedule.
Study objective
Primary:
To compare the effect of 6 months use of the CIS on adherence to ELLIPTA
maintenance therapy when both the subject and the HCP are supplied with data
from the maintenance sensor versus no data supplied to the subject and HCP (Arm
1 vs Arm 5)
Secondary:
To compare the effect of 6 months use of the CIS on adherence to ELLIPTA
maintenance therapy for the following aspects of the CIS: Arm 2 vs Arm 5, Arm 3
vs Arm 5, Arm 4 vs Arm 5. To compare the effect of the CIS on adherence to
ELLIPTA maintenance therapy of the individual CIS treatment arms versus no data
supplied to the subject and HCP. To evaluate the effect of 6 months use of the
CIS on a subject*s rescue medicine usage and asthma control. Safety.
Study design
Open-label, randomised, parallel group study consisting of 5 treatment arms.
1 month run-in on Relvar ELLIPTA (up to 3 months if needed) to confirm lack of
asthma controle (Asthma Control Test (ACT)) <20).
Randomization (1:1:1:1:1) to the following Arms for 6 months:
1. Data on Maintanance use supplied to Subject (app) and investigator
(dashboard).
2. Data on Maintanance use supplied to Subject (app).
3. Data on Maintanance use and Rescue use supplied to Subject (app) and
investigator (dashboard).
4. Data on Maintanance use and Rescue use supplied to Subject (app).
5. No data supplied to Subject or investigator.
All randomized subjects will be treated with Relvar ELLIPTA.
432 subjects (600 to be screened), see also sample size re-estimation in
section 5.2 of the protocol.
Intervention
Treatment with Relvar ELLIPTA. Different levels of information supply on
maintenance and rescue use.
Study burden and risks
Risk: Adverse events of Relvar ELLIPTA.
Burden:
5-11 visits in 7-9 months.
Complete physical examination: once.
Pregnancy test: 4-6 times (urine).
FeNO test 4-6 times.
Peak flow: 4-6 times.
Questionnaires: 6 (3-4 times), 1 (once).
Huis ter Heideweg 62
Zeist 3705 LZ
NL
Huis ter Heideweg 62
Zeist 3705 LZ
NL
Listed location countries
Age
Inclusion criteria
* Males and females at least 18 years of age.
* Documented diagnosis of asthma.
* Asthma Control Test <20 at screening.
* Asthma Control Test (ACT) score <20 at randomization.
* Non-smokers (never smoked or not smoking for >6 months with <10 pack years history).
* Subject must have been on maintenance therapy (Fixed dose combination ICS/LABA) for 3 months. See protocol page 31 for details).
* Background asthma medication such as anti-leukotrienes and oral corticosteroids are permitted provided the dose has been stable for 1 month prior to screening.
* Female participants of childbearing potential should agree to follow the contraceptive guidance in appendix 5 of the protocol during the treatment period and for at least 5 days after the last dose of study treatment.
Exclusion criteria
* History of life-threatening asthma. See protocol page 32 for details.
* Lower airway infection in the last 7 days before screening.
* COPD or other respiratory disorders. See protocol page 32 for details.
* Other diseases: See protocol page 32 for details.
* Ever received treatment with biological based therapy.
* Pregnancy or lactation.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-002266-45-NL |
| CCMO | NL63491.100.17 |
| Other | www.gskclinicalstudyregister.com 207040 |